cetuximab

What is the most important information I should know about cetuximab?

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, feverish, itchy, or short of breath during the injection.

Cetuximab has caused life-threatening side effects in a small number of patients. Your caregivers will watch you closely after you receive each dose of this medicine.

Cetuximab can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medicine.

What is cetuximab?

Cetuximab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Cetuximab is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.

Cetuximab is often used in combination with other cancer medicines or radiation treatment.

Cetuximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before I receive cetuximab?

You should not use this medicine if you are allergic to cetuximab or to mouse protein.

To make sure cetuximab is safe for you, tell your doctor if you have:

heart rhythm problems;

lung disease or a breathing disorder;

congestive heart failure;

coronary artery disease (clogged arteries); or

an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Whether you are a man or a woman, use effective birth control to prevent pregnancy while you are receiving cetuximab, and for at least 6 months after your treatment ends.

You should not breast-feed a baby while you are receiving cetuximab and for at least 60 days after your treatment ends. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How is cetuximab given?

Cetuximab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cetuximab must be given slowly, and the IV infusion can take up to 2 hours to complete. You may be given other medications to prevent certain side effects while you are receiving cetuximab.

Cetuximab is usually given once every week for 6 to 7 weeks or until your body no longer responds to the medication. Follow your doctor's dosing instructions very carefully.

Cetuximab is often used in combination with other cancer medications and/or radiation treatments. You may receive another cancer medicine 1 hour after your cetuximab injection.

If you are also being treated with radiation, you will receive your first cetuximab injection 1 week before your radiation treatment. Later doses are usually given 1 hour before radiation treatments.

Cetuximab has caused life-threatening side effects in a small number of patients. After each cetuximab infusion, your caregivers will watch you closely to make sure you do not have any serious side effects.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Cetuximab can have long lasting effects on your body. You may need to have blood tests for several weeks after your cetuximab treatment has ended. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your cetuximab infusion.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving cetuximab?

Avoid exposure to sunlight or tanning beds while you are receiving cetuximab and for at least 2 months after your treatment ends. Cetuximab can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of cetuximab?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

kidney problems --little or no urinating; painful or difficult urination; swelling in your feet or ankles; or

severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

mild itching or rash;

changes in your fingernails or toenails;

dry, cracked, or swollen skin;

headache;

diarrhea; or

infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cetuximab?

There may be other drugs that can interact with cetuximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about cetuximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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